BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3001792 · Received March 13, 2013

    Report

    Report Number
    3004209178-2013-03629
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Report Date
    February 22, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 37651 LOT# SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID 37642 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 37085-60 LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 37085-60 LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 3387S-40 LOT# V761180, IMPLANTED: 2011 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3387S-40 LOT# V761180, IMPLANTED: 2011 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED WHICH REPORTED THAT THE PATIENT DID NOT HAVE CONCERNS WITH HIS DEVICE OR THERAPY. THE PATIENT RECEIVED ASSISTANCE AND HIS CONCERNS WERE RESOLVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO YEARS PRIOR TO THE REPORT THE PATIENT ALMOST "FOUGHT" WITH AIRPORT SECURITY. THE PATIENT EVENTUALLY HAD TO GO THROUGH THE SECURITY GATE AND IT AFFECTED HIS DEVICE FOR ABOUT THIRTY MINUTES UNTIL IT FINALLY "CAME BACK." THE PATIENT STATED IT "STARTED GOING CRAZY" AND HE FELT "SHOCKING." THE PATIENT STATED IT FINALLY "STRAIGHTENED UP" AFTER HE TURNED IT OFF AND THEN BACK ON. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105482 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1